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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K873509
Device Name IDENTICULT-BL
Applicant
Scott Laboratories, Inc.
771 Main St.
West Warwick,  RI  02893
Applicant Contact PAUL CAMPOGNONE
Correspondent
Scott Laboratories, Inc.
771 Main St.
West Warwick,  RI  02893
Correspondent Contact PAUL CAMPOGNONE
Regulation Number866.2660
Classification Product Code
JTO  
Date Received08/31/1987
Decision Date 10/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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